Regulatory

The core driver of IDMP is to provide a common identification for drugs that can be referenced in Individual Case Safety Reports. The five ISO standards that make up IDMP create building blocks for storing product information and data; standardizing how routes of administration, dosage forms, and units are described; building in detail on active and inactive substances, and from there into pharmaceutical products (how things are consumed) into packaged products (how things are sold).

In 2012, five new ISO standards were approved to ensure unique identification of medicinal products and exchange between industry and authorities

Maintenance

Our webinar, IDMP Readiness, what you need to know about July 2016, may be viewed online here.

Contact us for a diagnostic worksheet to assess your readiness and discussion on how we can assist your efforts towards compliance.

So What’s Next?

There are many factors in choosing a new Regulatory system and we talked about quite a few of them here. If you would like to explore your Regulatory software options further please schedule a consultation with one of our Regulatory experts.